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    EudraCT Number:2014-000253-36
    Sponsor's Protocol Code Number:CD-IA-MEDI-551-1155
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-22
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-000253-36
    A.3Full title of the trial
    A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
    Estudio con doble enmascaramiento, controlado con placebo, con un período abierto para evaluar la eficacia y seguridad de MEDI-551 en sujetos adultos con neuromielitis óptica y trastornos del espectro de la neuromielitis óptica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
    Un estudio clínico para probar el efecto del fármaco MEDI-551 en neuromielitis óptica y trastornos del espectro de la neuromielitis óptica
    A.3.2Name or abbreviated title of the trial where available
    A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD
    Estudio doble ciego, controlado con placebo con período abierto para evaluar MEDI-551 en NMO/TENMO
    A.4.1Sponsor's protocol code numberCD-IA-MEDI-551-1155
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02200770
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1159-8686
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedImmune LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post codeMD 20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number900834223
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 1299440-37-1
    D.3.9.2Current sponsor codeMEDI-551
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typeMEDI-551 is a humanized, affinity-optimized, afucosylated immunoglobulin G1 kappa (IgG1k) monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
    Neuromielitis óptica y trastornos del espectro de la neuromielitis óptica (NMO/TENMO)
    E.1.1.1Medical condition in easily understood language
    Neuromyelitis optica (NMO) and NMO Spectrum Disorders, involve inflammation and damage of the optic nerve (optic neuritis), spinal cord (myelitis) and certain areas of the brain.
    La neuromielitis óptica y los trastornos del espectro de la neuromielitis óptica incluyen inflamación y daño del nervio óptico (neuritis óptica), médula espinal (mielitis) y ciertas áreas del cerebro.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029322
    E.1.2Term Neuromyelitis optica
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack
    Comparar la eficacia de MEDI-551 respecto a placebo para reducir el riesgo de una crisis de NMO/TENMO
    E.2.2Secondary objectives of the trial
    1. To characterize the long-term efficacy of MEDI-551 by means of annualized attack rate.
    2. To evaluate the safety and tolerability of MEDI-551
    3. To characterize the pharmacokinetic (PK) profile and immunogenicity of MEDI-551
    1. Determinar la eficacia a largo plazo de MEDI-551 mediante la tasa anualizada de crisis.
    2. Evaluar la seguridad y tolerabilidad de MEDI-551
    3. Definir el perfil farmacocinético (FC) y la inmunogenicidad de MEDI-551
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men and women 18 years or older with diagnosis of NMO/NMOSD.
    2) Confirmation of NMO/NMOSD status:
    a.) AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
    b.) AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
    3) Able and willing to give written informed consent and comply with the requirements of the study protocol.
    4) EDSS <= 7.5 (8 in special circumstances).
    5) Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
    1) Hombres y mujeres de 18 años de edad o más con diagnóstico de NMO/TENMO.
    2) Confirmación del estado de NMO/TENMO:
    a.) NMO/TENMO con AQP4 IgG positivo en suero con al menos una crisis con necesidad de tratamiento de rescate en el último año o dos crisis con necesidad de tratamiento de rescate en los últimos 2 años.
    b.) NMO con AQP4 IgG negativo en suero con al menos una crisis con necesidad de tratamiento de rescate en el último año o dos crisis con necesidad de tratamiento de rescate en los últimos 2 años.
    3) Capaz y dispuesto a dar su consentimiento informado por escrito y cumplir con los requisitos del protocolo de estudio
    4) EDSS <= 7,5 (8 en circunstancias especiales).
    5) Los hombres y mujeres con posibilidad reproductiva deben estar de acuerdo en utilizar un método anticonceptivo sumamente eficaz desde la selección hasta 6 meses después de la última dosis del producto en investigación.
    E.4Principal exclusion criteria
    1) Lactating and pregnant females.
    2) Treatment with any investigational agent within 4 weeks of screening.
    3) Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
    4) Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
    5) History of of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization.
    6) Receipt of the following at any time prior to randomization:
    a) Alemtuzumab
    b) Total lymphoid irradiation
    c) Bone marrow transplant
    d) T-cell vaccination therapy
    7) Receipt of rituximab or any experimental B-cell depleting agent, unless the subject´s B cells have returned to lower limit of normal (LLN) or greater prior to randomization.
    8) Receipt of IVIG within 1 month prior to randomization.
    9) Receipt of any of the following within 3 months prior to randomization:
    a) Natalizumab (Tysabri®)
    b) Cyclosporin
    c) Methotrexate
    d) Mitoxantrone
    e) Cyclophosphamide
    f) Tocilizumab
    g) Eculizumab
    10) History of Hepatitis B and/or Hepatitis C (Hep B/C at screening).
    11) Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection.
    12) History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization.
    1) Mujeres embarazadas o lactantes.
    2) Tratamiento con un producto en investigación en las 4 semanas tras la selección.
    3) Antecedentes conocidos de alergia o reacción grave a alguno de los componentes de la formulación del producto en investigación o antecedentes de anafilaxia tras recibir cualquier tratamiento biológico
    4) Infección viral o bacteriana conocida activa grave o cualquier otro episodio de infección que precise hospitalización.
    5) Datos de abuso de alcohol, drogas o sustancias químicas o antecedentes recientes de tal abuso menos de un año antes de la aleatorización.
    6) Recepción de los siguientes tratamientos en cualquier momento antes de la aleatorización:
    a. Alemtuzumab.
    b. Irradiación linfática total.
    c. Trasplante de médula ósea.
    d. Vacuna de linfocitos T.
    7) Recepción de rituximab o cualquier fármaco destructor de linfocitos B experimental, a menos que el recuento de linfocitos B del sujeto haya vuelto al límite inferior de la normalidad (LIN) o una cifra superior antes de la aleatorización.
    8) Recepción de IGIV en el mes previo a la aleatorización
    9) Recepción de alguno de los medicamentos siguientes en los 3 meses previos a la aleatorización:
    a. Natalizumab (Tysabri®)
    b. Ciclosporina.
    c. Metotrexato.
    d. Mitoxantrona.
    e. Ciclofosfamida.
    f. Tocilizumab.
    g. Eculizumab.
    10) Antecedentes de hepatitis B y/o hepatitis C (hepatitis B/C en el momento de selección)
    11) Antecedentes conocidos de inmunodeficiencia primaria (congénita o adquirida) o de una enfermedad subyacente, como infección por el virus de la inmunodeficiencia humana (VIH).
    12) Antecedentes de cáncer, aparte de un carcinoma espinocelular o basocelular de piel tratado, con éxito demostrado del tratamiento curativo más de 3 meses antes de la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Time to an NMO/NMOSD attack determined by Adjudication Committee.
    Tiempo hasta una crisis de NMO/TENMO determinado por el comité de adjudicación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    on or before Day 197
    durante o antes del dia 197
    E.5.2Secondary end point(s)
    1) Attack Rate
    2) Number of subjects with Adverse Events
    3) PK profile
    4) Incidence of anti-drug antibodies (ADAs) directed against MEDI-551
    1) Tasa de crisis
    2) Número de sujetos con acontecimientos adversos
    3) Perfil farmacocinético
    4) Incidencia de anticuerpos contra el fármaco (ACF) dirigidos contra MEDI-551
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Randomized-controlled Period and End of Study
    Fin del período controlado aleatorizado y final del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Período de extensión abierto
    Open label extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Hong Kong
    Korea, Republic of
    Moldova, Republic of
    New Zealand
    Russian Federation
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study. This will occur when the last subject completes the 52-week safety follow up.
    El final del estudio se define como la fecha de la última visita/evaluación especificada en el protocolo (incluido el contacto telefónico) del último sujeto del estudio. Tendrá lugar cuando el último sujeto complete el período de seguimiento de la seguridad de 52 semanas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 212
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Revert to standard of care for the condition
    Regreso al tratamiento estándar para la enfermedad
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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